Identify, quantify and verify materials—from incoming inspection through finished product
To ensure product quality and consumer safety, pharmaceutical and biotechnology manufacturers must verify materials throughout production. The Thermo Scientific TruScan RM Handheld Analyzer uses lab-proven Raman spectroscopy to perform accurate and reliable material identification at the point of need, minimizing the need for costly and time-consuming laboratory sampling tests.
The analyzer’s non-destructive point-and-shoot sampling principle facilitates rapid verification of a broad range of chemical compounds through sealed packaging to minimize the risk of contamination and exposure.
The TruScan RM Handheld Analyzer:
- Meets current good manufacturing practices (cGMP) and 21 CFR Part 11 requirements
- Is compliant with United States Pharmacopeia (USP) Chapter <1120> on Raman spectroscopy
- Is compliant with European Pharmacopeia (EP) 8.7 general chapter
<2.2.48> on Raman spectroscopy
- Features a rugged design that's chemical and drop resistant
- Weighs less than 2 lbs (0.9 kg)
- Incoming raw material identification (RMID)
- Dispensing of materials during API manufacture
- Finished product inspection
Brand security application:
- Identification of falsified (counterfeit) medicines
Improve productivity and efficiency, minimize lab sampling with the TruScan RM analyzer:
The technology behind the TruScan RM analyzer is Raman spectrometry, a type of vibrational spectroscopy that characterizes materials based on measured patterns of vibrational frequencies, or wavelengths. The analyzer emits a laser light at 785nm and detects scattered photons at other wavelengths. The scattered light is a unique fingerprint for that material, and the TruScan RM analyzer uses this "spectral fingerprint" to identify raw material or finished drug products. The 785nm laser wavelength provides optimal balance for measuring most pharmaceutical materials without compromising spectral resolution or Raman signal intensity.
Patented chemometrics engine
The TruScan RM analyzer’s patented multivariate residual analysis offers the most effective chemometric solution for material identification—with two spectral pre-processing options—that is easy to operate in challenging environments and sampling conditions.
The TruScan RM analyzer acquires the Raman spectrum of the material and, in real time, determines the uncertainty of that measurement, given factors such as the sample characteristics, instrument telemetry, environment and testing environment. Since the software models the uncertainty (or in statistical terms, standard deviation) directly, there is no calibration or user modeling involved with method development.
Learn more about our probabilistic approach for material verification and identification in this white paper.
TruTools chemometrics capability
Go beyond simple material ID and identify and quantify more materials—anywhere in the plant. With the Thermo Scientific TruTools chemometrics package embedded in the TruScan RM analyzer, users can build custom, advanced qualitative and quantitative models for complex materials analysis problems. Applications include, but are not limited to:
- Raw Material Identification: Ensure the integrity of your inbound raw materials, including those with minimal spectral differences (e.g., ethanol vs. methylated spirits).
- Finished Product Identification: Discriminate low API–dosage tablets from placebos.
- Component Threshold Testing: Quantify up to 10 components, then set PASS/FAIL thresholds for fast decision making (e.g., glycerin contaminated with DEG).
- At-line Process Monitoring: Endpoint determination of distillations, reaction monitoring and component quantification of powder blended mixtures.
By law, pharmaceutical manufacturers must identify and verify all incoming materials. Current Good Manufacturing Processes (cGMP) require that not only incoming raw materials but all in-process materials be tested for identity, strength, quality, and purity throughout the manufacturing process.
Make sure your QA/QC program is compliant. Download the free eBook, What You Need to Know About Field-Based Material Identification and Authentication for Pharmaceuticals.
Learn how the TruScan RM analyzer becomes a more powerful spectrometer with the TruTools chemometrics capability, which enables users to build custom models to be deployed on the analyzer for materials analysis at the point of need.